Use of Ceftaroline 30μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in Clinical Infections Against:
Gram-positive Microorganisms
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus pneumoniae
Gram-negative Microorganisms
Escherichia coli
Klebsiella pneumoniae
Klebsiella oxytoca
Haemophilus influenzae

Active In Vitro Against:
Gram-positive Microorganisms
Streptococcus dysgalactiae
Gram-negative Microorganisms
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Moraxella catarrhalis
Morganella morganii
Proteus mirabilis
Haemophilus parainfluenzae

Device Description

Ceftaroline 30ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Ceftaroline supplied by the drug manufacturer. Each Ceftaroline disk is clearly marked on both sides with the agent and drug content. Ceftaroline cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ceftaroline disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Aqar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.

AI/ML Overview

This submission for the Ceftaroline 30µg BBL Sensi-Disc Antimicrobial Susceptibility Test Disks is for an in vitro diagnostic (IVD) device. The provided text outlines the intended use, device description, and comparison to a predicate device, focusing on its function in determining bacterial susceptibility to Ceftaroline. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format typically required for medical device clinical studies in the context of human imaging or diagnostic algorithms.

The document refers to the Ceftaroline drug package insert, "Microbiology" for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This indicates that the performance of the antimicrobial susceptibility test disk is tied to the established performance and microbiology data of the Ceftaroline drug itself, which would have undergone rigorous clinical trials for its efficacy and determination of susceptibility breakpoints. The 510(k) submission is confirming that the method of testing (using the Sensi-Disc) provides results consistent with the drug's known microbiological profile.

Therefore, many of the requested points cannot be directly answered from the provided text, as they pertain to a different type of device evaluation (e.g., studies involving human readers, imaging data, or AI algorithms).

Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance in terms of sensitivity, specificity, accuracy, or other typical metrics for a diagnostic algorithm. Instead, for IVD susceptibility testing, the acceptance criteria are based on comparing zone sizes around the disk to established zone size ranges for individual antimicrobial agents, which are determined by the antimicrobic manufacturer and FDA approved under the drug's NDA (Number 200327). These are also guided by CLSI/NCCLS standards (M2 and M100). The "performance" of the device is its ability to produce inhibition zone diameters that consistently fall within these established ranges for control organisms and accurately categorize clinical isolates as Susceptible (S), Intermediate (I), or Resistant (R) according to the FDA drug insert and CLSI/NCCLS documents.

Specific performance data for this device is explicitly stated to be in the Ceftaroline drug package insert, "Microbiology." Therefore, a table of this data cannot be created from the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. It would be contained within the "Microbiology" section of the Ceftaroline drug package insert. For antimicrobial susceptibility testing, the "test set" would typically consist of a variety of bacterial isolates, including both wild-type and resistant strains, collected from various clinical sources.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For antimicrobial susceptibility testing, "ground truth" is typically established by reference methods like broth microdilution or agar dilution as defined by CLSI. The establishment of these reference values usually involves a consensus process by expert microbiologists and laboratory professionals within organizations like CLSI. It isn't tied to individual experts interpreting results, but rather to standardized laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods like 2+1 are typically used in scenarios where human interpretation of complex data (e.g., medical images) needs consensus. For antimicrobial susceptibility testing, the measurement of inhibition zones is objective, and interpretive categories (S/I/R) are determined by comparing measurements to predefined breakpoints, not by expert consensus on each individual test result.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable and not provided. The device is a physical disk for manual susceptibility testing, not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes related to AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical Sensi-Disc; it is not an algorithm. The "algorithm" for interpretation involves measuring a zone diameter and comparing it to a published table, which inherently involves human observation and measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for antimicrobial susceptibility testing is established by reference methods such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC) of the drug against a particular bacterial isolate. These reference methods are standardized by organizations like CLSI and are based on extensive microbiological data. The zone diameter breakpoints for the Sensi-Disc are then correlated to these reference MIC values.

8. The sample size for the training set

This information is not explicitly provided. For IVD devices like this, the "training set" doesn't refer to an AI training set. Instead, it refers to the collection of bacterial isolates used during the development and validation of the disk diffusion method and the establishment of interpretive zone diameter breakpoints. This data would be found in the microbiological studies supporting drug approval and CLSI guidelines.

9. How the ground truth for the training set was established

Similar to point 7, the "ground truth" for establishing the correlation between zone diameters and MICs (which leads to the S/I/R interpretive categories) is based on standardized reference antimicrobial susceptibility testing methods (e.g., broth microdilution or agar dilution) performed on a large collection of characterized bacterial isolates. These methods provide the MIC values, against which the zone diameters from the disk diffusion method are correlated. This process is outlined in CLSI guidelines and validated during the drug approval process.

Summary

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OCT 18 2011 K112580

510(k) Submission Ceftaroline 30µg BBL TM Sensi-Disc TM CONFIDENTIAL AND PROPRIETARY

510(k) SUMMARY

SUBMITTED BY:	Becton Dickinson and Company7 Loveton CircleSparks, MD 21152Phone 410-316-4975Fax: 410-316-4499
CONTACT NAME:	Katie Coyle, Regulatory Affairs Specialist
DATE PREPARED:	September 2, 2011
DEVICE TRADE NAME:	Ceftaroline 30µg, BBL™ Sensi-Disc™ AntimicrobialSusceptibility Test Disks
DEVICE COMMON NAME:	Antimicrobial Susceptibility Test Disks
DEVICE CLASSIFICATION:	21 CFR§866.1620, Class II (Product Code JTN),Susceptibility Test Disks, Antimicrobial
PREDICATE DEVICE:	Other BBL™ Sensi-Disc™(e.g., Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

INTENDED USE:

Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ceftaroline 30μg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ceftaroline of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 200327.

Becton, Dickinson and Company

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510(k) SUMMARY

Indications for Use:

Use of Ceftaroline 30µg BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30ug has been shown to be active in vitro aqainst most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in Clinical Infections Against:

Gram-positive Microorganisms

Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae

Gram-negative Microorganisms

Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae

Active In Vitro Against:

Gram-positive Microorganisms Streptococcus dysgalactiae

Gram-negative Microorganisms

Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morqanii Proteus mirabilis Haemophilus parainfluenzae

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DEVICE DESCRIPTION:

DEVICE PRINCIPLE:

Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Aqar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the disks are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of the FDA drug insert and/or CLSI/NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests) and of CLSI/NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").

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DEVICE COMPARISON:

The BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ceftaroline 30μg is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks – Ciprofloxacin 5 uq in that:

Both methods are for antimicrobial susceptibility testing using paper disks . impregnated with an antimicrobial agent.
. Both methods have the same intended use.
Both methods provide the user with antimicrobic minimum inhibitory concentration . (MIC) results based on measurements of zone diameters.
. Both methods require the user to determine categorical interpretations (S//R) using the measured zone diameters against CLSI/NCCLS Approved Standards M2 and M100.
. Both methods use pure cultures of bacterial isolates.

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ceftaroline 30μg differs from the BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 ug in that:

BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Ceftaroline 30ug is a . susceptibility test that uses disks impregnated with the antimicrobic Ceftaroline at a concentration of 30pg while the BBL™ Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 µg.
BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk -- Ceftaroline 30 µg is a . susceptibility test used to test a different battery of microorganisms than the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 μg.

SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the Ceftaroline drug package insert. "Microbiology".

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Becton Dickinson and Company c/o Ms. Katie Coyle Regulatory Affairs Specialist 7 Loveton Circle Sparks, MD 21152

OCT 1 8 2011

Re: K112586

Trade/Device Name: Ceftaroline 30μg, BBLTM Sensi -DiscTM Regulation Number: 21 CFR§866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: September 2, 2011 Received: September 6, 2011

Dear Ms. Coyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page- 2 - Ms. Katie Coyle

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Jal atozr

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K l ( 2 586

Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Ceftaroline 30μg

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Gram-positive MicroorganismsStaphylococcus aureus (including methicillin-susceptible and-resistant isolates)Streptococcus pyogenesStreptococcus agalactiaeStreptococcus pneumoniae	Gram-negative MicroorganismsEscherichia coliKlebsiella pneumoniaeKlebsiella oxytocaHaemophilus influenzae
Active In Vitro Against:
Gram-positive Microorganisms	Gram-negative Microorganisms

رقش-انجو ative Micr Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis Haemophilus parainfluenzae

Prescription Use V (Per 21 CFR 801 Subpart D)

Streptococcus dysgalactiae

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Lindale L. Pope

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112586

Becton, Dickinson and Company

Regulation Number and Section

§ 866.1620 Antimicrobial susceptibility test disc.

(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).